NIPH Clinical Trials Search

Safety, tolerability and pharmacokinetics of GIA632 in Japanese healthy participants

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	24/12/2025
Target sample size	40
Countries of recruitment
Study type	Interventional
Intervention(s)	GIA632 (i.v. or s.c.) Placebo (i.v. or s.c.)

Outcome(s)

Primary Outcome	AEs (treatment emergent), vital signs, ECG including QTcF, labs (hematology, clinical chemistry, coagulation, urinalysis)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 55age old
Gender	Both
Include criteria	- Able to communicate well with the investigator, to understand and comply with the requirements of the study. - Healthy Japanese male and non-childbearing potential female participants 18 to 55 years of age, inclusive, and in good health as determined by past medical history, physical examination, vital signs, 12-lead Electrocardiogram (ECG), and laboratory tests at screening and baseline. - Weigh at least 40.0 kg (female) and 50.0 kg (male), up to a maximum of 120 kg, with a body mass index (BMI) within the range of 18.0- 29.9 kg/m2.
Exclude criteria	- Use of other investigational drugs at the time of screening, or within a period corresponding to less than 5 half-lives of the drug before screening, or within 30 days, whichever is longer. - Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or over the counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing. - History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. - Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline.